The study explores the addition of pembrolizumab to temozolomide-based radiotherapy in patients with newly diagnosed glioblastoma.
Name: PembrolizumabDescription: Pembrolizumab will be added to standard of careType: Drug
Description: To explore whether the addition of pembrolizumab to standard temozolomide-based radiochemotherapy improves the outcome of newly diagnosed glioblastoma or gliosarcoma patients, determined by the overall survival rate at 12 monthsMeasure: Overall survival at 12 months Time: At 12 months
Description: HRQoL will be assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) version 3. Scoring: 0 to 100. Higher scores mean a better level of functioning.Measure: Health-related Quality of life (HRQol) Time: From the inclusion in the study until the end of follow-up (up to approximately 36 months)
Description: Expression levels of PD-L1 will be determined in the tumor tissue and correlated with response as determined by MRI and progression-free as well as overall survivalMeasure: Correlation of programmed cell death (PD-1) ligand 1 (PD-L1) expression levels with response to treatment and outcome Time: From the inclusion in the study until the end of follow-up (up to approximately 36 months)
Single Group Assignment
There is one SNP
- Newly diagnosed glioblastoma or gliosarcoma as confirmed by local histopathology - The patient is at least 18 years of age on day of signing informed consent - Absence of isocitrate dehydrogenase (IDH)1 R132H mutation by immunohistochemistry - A maximum dose of 4 mg/day dexamethasone or equivalent doses for other corticosteroids, which has been stable or decreased for ≥5 days prior to start of radiotherapy - Patient who are treated with anticoagulants are on a stable dose for at least two weeks prior to start of radiotherapy (RT) - The patient is male or a non-pregnant, non-lactating female - Females of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test within 2 weeks prior to receiving the first dose of study medication. --- R132H ---